FDA 483 - Ming Fai Industrial (Shenzhen) Co LTD - August 11, 2017

An FDA inspection of Mingfai Industrial (Shenzhen) Co., Ltd., an OTC drug manufacturer, revealed significant deficiencies in their production, quality control, laboratory, and equipment systems. The firm lacked adequate written procedures, process validation, proper testing, and robust quality unit oversight. These issues indicate a failure to ensure drug product identity, strength, quality, and purity.